Airway Inflammation and Remodeling in Asthma and COPD.

NCT ID: NCT02069054

Last Updated: 2016-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-08-31

Brief Summary

Asthma and chronic obstructive pulmonary disease (COPD) are inflammatory airway diseases. Although the clinical features of asthma and COPD may be similar, the pathogenesis of these diseases differs in many aspects.

The aim of this study is:

• to evaluate airway inflammation in asthma and COPD,
• to evaluate airway remodeling in asthma and COPD as compared to healthy subjects,
• to assess the relationship between markers of airway inflammation and airway remodeling in asthma and COPD patients.

Material and methods:

• mild to moderate asthma patients diagnosed in accordance with Global Initiative for Asthma (GINA) guidelines,
• mild to moderate COPD patients diagnosed in accordance with Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines,
• healthy subjects as controls.

Airway inflammation is assessed in induced sputum (IS), exhaled breath condensate (EBC), bronchoalveolar lavage fluid (BALF) and specimens from endobronchial forceps biopsy. Airway wall thickness is evaluated in high resolution computed tomography (HRCT), endobronchial ultrasound (EBUS) and basement membrane thickness (BMT) in biopsy specimens.

We plan to compare airway inflammation and features of airway remodeling in asthma and COPD patients.

Conditions

Asthma; COPD

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Asthma

Patients with mild to moderate asthma diagnosed in accordance with GINA

No interventions assigned to this group

COPD

Patients with mild to moderate COPD diagnosed in accordance with GOLD

No interventions assigned to this group

Control

Healthy subjects

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• a clinical diagnosis of asthma or COPD in accordance with GINA or GOLD, respectively
• control group - healthy volunteers without any history of lung disease

Exclusion Criteria

• age below 18 years
• exacerbation in the past 6 weeks
• inhaled corticosteroid therapy at least 6 weeks prior to study enrollment
• significant co-morbidities

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw 02-097

Warsaw, , Poland

Countries

Poland

Other Identifiers

IPU-DIMPA-WUM13(2)

Identifier Type: -

Identifier Source: org_study_id